NEUROCOGNITIVE, NEUROIMAGING, AND NEUROPSYCHIATRIC CORRELATES OF HIV INFECTION

Release Date:  December 14, 2000

RFA:  MH-01-007

National Institute of Mental Health
 (http://www.nimh.nih.gov/)
National Institute on Drug Abuse
 (http://www.nida.nih.gov/)
National Institute of Child Health and Human Development
 (http://www.nichd.nih.gov/)

Letter of Intent Receipt Date:  February 13, 2001
Application Receipt Date:       March 20, 2001

THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  THIS RFA INCLUDES 
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED 
WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA.

PURPOSE

The National Institute of Mental Health (NIMH), the National Institute on 
Drug Abuse (NIDA) and the National Institute of Child Health and Human 
Development (NICHD) invite research grant applications through this Request 
for Applications (RFA) to support research focused on the neuropsychological, 
neurobehavioral, neuroimaging and neuropsychiatric correlates of human 
immunodeficiency virus/central nervous system (HIV/CNS) disease.  As new and 
improved therapeutic interventions are becoming available for controlling HIV 
disease progression, the importance of non-invasive monitoring of HIV/CNS 
disease using neuropsychological/neurobehavioral approaches is necessary for 
treatment monitoring and disease progression.  These approaches offer promise 
for early diagnosis and can be informative regarding the neural bases 
underlying functional alterations.  Advanced structural and functional 
neuroimaging methods (sometimes in combination with behavioral methods) offer 
the opportunity to examine relevant brain circuitry in HIV disease and 
identify clinically significant abnormalities.  The psychiatric sequelae 
frequently found in an immuno-compromised state interact with other chronic 
medical conditions and their involvement in HIV disease can also be 
understood through the use of neurobehavioral and neuroimaging modalities.  
The main objective of this RFA is to foster investigations that will identify 
and clarify the critical questions in the assessment and etiology of 
neurobehavioral complications of HIV.  Multidisciplinary research teams and 
collaborative alliances are encouraged but not required.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas.  This RFA, Neurocognitive, 
Neuroimaging, and Neuropsychiatric Correlates of HIV, is related to the 
priority area of neurological complications of HIV infection.  Potential 
applicants may obtain a copy of “Healthy People 2010” at:   
http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign for-profit and non-
profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and eligible 
agencies of the Federal government.  Foreign institutions are not eligible 
for small grants.  Racial/ethnic minority individuals, women, and persons 
with disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) research project 
grant (R01) and small research grant (R03) award mechanisms.  Collaborative 
R01s will also be accepted.  The total project period for an application 
submitted in response to this RFA may not exceed 5 years.  R03 grants are 
limited to two years and are not renewable.  The R03 is limited to $50,000 
direct costs for each of these 2 years.  This RFA is a one-time solicitation.  
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  Future unsolicited competing 
continuation applications will compete with all investigator-initiated 
applications and be reviewed according to the customary peer review 
procedures.  The anticipated award date is September 30, 2001.

For the purposes of this RFA, the guidelines provided in PAR-98-017 
(http://grants.nih.gov/grants/guide/pa-files/PAR-98-017.html)are to be 
followed for applications using the Collaborative R01 mechanism.

Information and application instructions for the NIMH Small Grant are 
available in the NIH Guide for Grants and Contracts at: 
http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html.

Information and application instructions for the NICHD Small Grant are 
available in the NIH Guide for Grants and Contracts at: 
http://grants.nih.gov/grants/guide/pa-files/PAR-99-126.html.

For applications requesting up to $250,000 direct costs per year, specific 
application instructions have been modified to reflect MODULAR GRANT and 
JUST-IN-TIME streamlining efforts being examined by NIH.  Complete and 
detailed instructions and information about Modular Grant applications can be 
found at:  http://grants.nih.gov/grants/funding/modular/modular.htm.  

Applications that request more than $250,000 in any year must use the 
standard PHS 398 (rev. 4/98) application instructions.

FUNDS AVAILABLE

The NIMH intends to commit approximately $1,500,000 to fund 6 to 8 new and/or 
competitive continuation grants in response to this RFA.  The NIDA intends to 
commit approximately $1,000,000 to fund 4 to 6 new and/or competitive 
continuation grants in response to this RFA.  The NICHD intends to commit 
approximately $250,000 to fund 1 new and/or competitive continuation grant 
responding to this RFA.  An applicant may request a project period of up to 5 
years for an R01 application.  Because the nature and scope of the research 
proposed may vary, it is anticipated that the size of each award will also 
vary.  It is expected that direct costs will be awarded in modules of 
$25,000; however, program and grants management adjustments may be necessary 
prior to award.  Although the financial plans of the Institute provide 
support for this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of applications 
of outstanding scientific and technical merit.  At this time, it is not known 
whether competing renewal applications will be accepted and/or if this RFA 
will be reissued.

RESEARCH OBJECTIVES

Background

HIV not only leads to immunodeficiency but also invades the CNS shortly after 
infection.  HIV-associated dementia complex (ADC) and less severe MCMD 
develop in 20 percent of patients with AIDS and are associated with HIV-1 
infection of macrophages and microglia in the CNS.  Milder forms of 
neurocognitive impairment without significant loss of daily function may 
precede such syndromes.  In general, the clinical manifestations of these 
disorders occur in the more advanced stages of disease when ribonucleic acid 
(RNA) viral load increases and CD4 counts decrease; these changes are linked 
to release of neurotoxic metabolites and cytokines by infected macrophages 
and microglia.  Ultimately, ADC patients show dramatic loss of brain volume 
along with progressive deficits in psychomotor function and cognition.   
Although productive infection of the CNS is clearly a prerequisite for the 
development of ADC, the role of viral replication within the CNS for the 
pathogenesis of this disorder has not yet been demonstrated conclusively.  
Previous studies have shown that HIV infection produces structural damage to 
the brain, particularly to the cerebral white matter, striatum and limbic 
system.  Neuropathologic data are generally consistent with the “subcortical” 
nature of the neurologic deficits.  A growing body of evidence suggests that 
neuronal death and dysfunction result from secondary events, which follow 
infection and/or activation of mononuclear phagocytes in the CNS.  
Additionally, drugs of abuse have been shown to suppress immunity and 
therefore interact with HIV to alter the course of the disease.  It is not 
known how this interaction of HIV and drug abuse affects brain degenerative 
processes and how these changes are reflected in behavioral/neurocognitive 
impairment.

The development of precise criteria for the diagnosis of ADC and related 
disorders has been difficult, in part because of the lack of objective 
measures of functional impairment, since neurocognitive dysfunction in AIDS 
manifests as degrees of dysfunction from minor (no significant loss of daily 
function) to profound (ADC).  Unfortunately, by the time functional 
impairment develops in patients, significant brain atrophy may occur, 
suggesting that clinical manifestations of cognitive impairment often herald 
significant structural brain damage and cellular loss.  In addition, the 
onset of HIV-related CNS pathology is difficult to predict, and the course is 
variable within the HIV positive (HIV+) population.  Furthermore, there is 
evidence for some dissociation between viral replication in the brain and 
systemic viral load levels.  This dissociation further complicates the 
accurate assessment of CNS damage and hinders the development of more 
specific treatments to prevent or ameliorate CNS dysfunction.

For these reasons, there is a need for direct non-invasive, assessments of 
brain function that are sensitive to the earliest effects of HIV, appropriate 
for monitoring the status of the brain over time and informative with respect 
to the neural bases (anatomy) of the underlying functional alterations.  The 
use of sensitive neuropsychological and neurobehavioral tests are presently 
the best available means of detecting the CNS effects of HIV and research 
employing these techniques is urgently needed.  In addition, functional 
magnetic resonance imaging (fMRI) techniques, particularly in combination 
with structural imaging approaches (e.g., magnetic resonance imaging (MRI) 
and fMRI) show promise as early diagnosis methods since they could combine 
the advantage of sensitive behavioral assessments with the anatomical 
specificity of fMRI and other imaging modalities.  Advanced structural and 
functional neuroimaging techniques provide opportunities to identify 
clinically significant abnormalities that are associated with psychiatric 
complications.  Most of the initial HIV imaging studies addressed the CNS 
complications of AIDS in patients with more advanced disease and 
clarification is needed on imaging abnormalities during the asymptomatic 
period.  

With the exception of a large literature addressing cognitive impairment and 
dementia, limited published information is available on other HIV-related 
neuropsychiatric complications, such as psychotic disorders and mood 
disorders.  Because many of the medical illnesses that patients develop when 
they become immunocompromised involve the brain and may mimic psychiatric 
conditions, research is needed to differentiate the features of “true” 
psychiatric conditions and those secondary to immunocompromise.  The 
psychiatric sequelae of HIV infection and AIDS are not final end points.  At 
each step the psychiatric consequences (as well as the sequelae of alcohol 
and drug abuse) become part of the system of influences determining 
subsequent behavior, and thus, their consequences may become etiologic 
factors themselves.  Psychiatric disorders, including affective disorders 
(both major depression and mania), dementia, addiction, personality 
disorders, are common and severely impairing in patients with HIV infection.  
These disorders have tremendous impact on subjective well-being, self-care, 
level of overall function, adherence with medical treatment and continuation 
of risk behaviors with implications for further HIV transmission.  Research 
is essential to understand these psychiatric sequelae and how they interact 
with the neural-damaging and neurotoxic effects of HIV and the resulting 
neurocognitive dysfunction.

Areas of Interest

Examples of research that would be an appropriate response to this RFA 
include, but are not limited to, the following:  (Investigators are 
particularly encouraged to use existing databases and repositories of 
biologic materials in the three research areas below to address critical 
hypotheses in applications responding to this RFA.)   

Neurocognitive/Neurobehavioral

o  Methodological and longitudinal studies of changes in neuropsychological 
patterns and neuropsychological deficits in HIV-infected individuals (e.g., 
reliability studies, detection of subtle/early neuropsychological changes in 
at-risk populations, identify neurocognitive status over time, normative 
neuropsychological data for underserved minority populations)  

o  Antemortem-postmortem studies of the association between neurocognitive 
dysfunction, HIV encephalitis neurodegeneration, neuroprotective effects and 
anatomic/functional brain changes

o  Studies that assess the direct correlation between brain changes and 
neuropsychological/neurocognitive status in drug abusing HIV-positive 
individuals	

o  Correlative studies of neuropsychologic impairment and improvement with 
surrogate laboratory markers of the spectrum of injury to the brain in HIV-
infected individuals (e.g., HIV RNA in CSF or plasma compartments, markers of 
systemic immune function and HIV replication)

o  Studies that assess gender-related differences in drug abusing HIV-
positive individuals in terms of neurocognitive function

o  Research specifically focused on neurocognitive and neurobehavioral HIV-
related changes over time in children and youth with particular emphasis on 
impact of therapy
 
o  Studies of the ecological validity of neuropsychological impairment/minor 
cognitive motor disorder (e.g., translating neuropsychological impairment to 
“real life” activities such as adherence and management of complex drug 
regimens, returning to work, quality of life), the adoption of compensatory 
strategies to overcome disabilities, and the effects of neurocognitive 
impairment on family and social adaptation

o  Research on method development for the delay, prevention and treatment of 
neurocognitive impairment, for example, through targeted cognitive 
rehabilitation techniques

Neuroimaging

o  Improved statistical approaches and innovative neuroimaging methods (e.g., 
repeated measures of in vivo morphometry, more sophisticated assessments in 
cerebral white matter)

o  Novel neuroimaging techniques (PET, MR spectroscopy, fMRI) related to HIV 
disease progression, HIV-induced CNS degeneration and dysfunction, 
neuropsychiatric symptom status, neuropsychologic performance, cognitive and 
memory processes, treatment monitoring and drug treatment interactions with 
drugs of abuse

o  Structural and/or functional neuroimaging techniques to characterize brain 
changes over the course of infection in drug abusing HIV-positive 
individuals, as well as over the course of treatment

o  Studies in HIV infected individuals to identify non-invasive surrogate 
markers for viral load within the CNS, assess drug and alcohol comorbidity 
and monitor CNS disease progression and remission

o  Research to identify regional metabolic changes reflective of brain injury 
or to study metabolic changes with other parameters that are reflective of 
HIV-induced brain injury, such as astrocytosis or changes in synaptophysin 
levels

o  Studies that assess brain activation using neuroimaging techniques and 
neurocognitive tasks to determine effects of HIV infection as a function of 
disease progression and drug status
  
o  Research to identify early morphologic or metabolic alterations associated 
with onset of cognitive impairment and to confirm neuroimaging findings with 
postmortem neuropathological findings 

Neuropsychiatry

o  Studies of Axis I and Axis II psychopathology in HIV disease (e.g., 
differentiating preexisting psychopathology from new onset psychiatric 
disorders)

o  Studies of the influence of comorbid mental and substance abuse disorders 
in HIV- infected individuals (e.g., immunomodulatory properties of drugs of 
abuse and reduced adherence related to mental disorders)

o  Studies of psychiatric sequelae of HIV infection and AIDS (e.g., grief 
response and reactions to disability, exacerbation of psychopathology or 
development of new primary psychiatric symptoms)

o  Studies on individual difference factors related to HIV disease (e.g., 
personality or temperamental variables such as impulsivity, their interaction 
with Axis I and II pathology and HIV neurocognitive deficits)

o  Studies of the interaction of psychiatric complications with chronic 
medical disorders, opportunistic infections and systemic abnormalities that 
impact on neuronal function

o  Studies that tailor adherence and prevention strategies to 
neuropsychiatric symptoms (e.g., address the influence of personality 
variables and psychiatric disorders on adherence to psychosocial 
interventions and complex drug regimens, coping skills and quality of life)

o  Treatment studies in HIV infection and AIDS examining neuropsychiatric 
syndromes, neurocognitive/motor dysfunction and neuroimaging correlates, 
behavioral effectiveness and functional outcomes and interactions of 
psychotropics, drugs of abuse and antiretrovirals

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their sub-populations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided indicating that inclusion 
is inappropriate with respect to the health of the subjects or the purpose of 
the research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43). 

All investigators proposing research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines are available at:  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by 
the NIH, unless there are scientific and ethical reasons not to include them.  
This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html

Investigators also may obtain copies of the policy from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, Internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed research, the name, address, and telephone 
number of the Principal Investigator, the identities of other key personnel 
and participating institutions, and the number and title of the RFA in 
response to which the application may be submitted.  Although a letter of 
intent is not required, is not binding, and does not enter into the review of 
a subsequent application, the information that it contains allows Institute 
staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent to Dr. David M. Stoff at the address 
listed under INQUIRIES, by the receipt date listed.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms are available at most institutional 
offices of sponsored research and from the Division of Extramural Outreach 
and Information Resources, National Institutes of Health, 6701 Rockledge 
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, Email: 
GrantsInfo@nih.gov.  The application is also available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

Applicants are strongly encouraged to contact the program contacts listed 
under INQUIRIES with any questions regarding the responsiveness of their 
proposed project to the goals of this RFA.

SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets.  Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only 
when there is a possibility for an award.  It is anticipated that these 
changes will reduce the administrative burden for the applicants, reviewers 
and Institute staff.  The research grant application form PHS 398 (rev. 4/98) 
is to be used in applying for these grants, with the modifications noted 
below.

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up 
to a total direct cost request of $250,000 per year.  (Applications that 
request more than $250,000 direct costs in any year must follow the 
traditional PHS 398 application instructions.)  The total direct costs must 
be requested in accordance with the program guidelines and the modifications 
made to the standard PHS 398 application instructions described below:

PHS 398

o  FACE PAGE:  Items 7a and 7b should be completed, indicating Direct Costs 
(in $25,000 increments up to a maximum of $250,00) and Total Costs [Modular 
Total Direct plus Facilities and Administrative (F&A) costs] for the initial 
budget period.  Items 8a and 8b should be completed indicating the Direct and 
Total Costs for the entire proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD:  Do not complete Form Page 
4 of the PHS 398.  It is not required and will not be accepted with the 
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT:  Do not complete the 
categorical budget tables on page 5 of the PHS 398.  It is not required and 
will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION:  Prepare a Modular Grant Budget Narrative 
page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for 
sample pages.) At the top of the page, enter the total direct costs requested 
for each year.  This is not a Form page.

Under Personnel, list all project personnel, including their names, percent 
of effort, and roles on the project.  No individual salary information should 
be provided.  However, the applicant should use the NIH appropriation 
language salary cap and the NIH policy for graduate student compensation in 
developing the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the 
nearest $1,000.  List the individuals/organizations with whom consortium or 
contractual arrangements have been made, the percent effort of all personnel, 
and the role on the project.  Indicate whether the collaborating institution 
is foreign or domestic.  The total cost for a consortium/contractual 
arrangement is included in the overall requested modular direct cost amount.  
Include the Letter of Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o  BIOGRAPHICAL SKETCH:  The Biographical Sketch provides information used by  
reviewers in the assessment of each individual's qualifications for a 
specific role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all key personnel, following the instructions below.  No more than three 
pages may be used for each person.  A sample biographical sketch may be 
viewed at:  http://grants.nih.gov/grants/funding/modular/modular.htm 

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years;
- List selected peer-reviewed publications, with full citations.

o  CHECKLIST:  This page should be completed and submitted with the 
application.  If the F&A rate agreement has been established, indicate the 
type of agreement and the date.  All appropriate exclusions must be applied 
in the calculation of the F&A costs for the initial budget period and all 
future budget years.

The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review.

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application.  Type the RFA 
number (MH-01-007) on the label.  Failure to use this label could result in 
delayed processing of the application such that it may not reach the review 
committee in time for review.  In addition, the RFA title and number, 
Neurocognitive, Neuroimaging, and Neuropsychiatric Correlates of HIV 
Infection, MH-01-007, must be typed on line 2 of the face page of the 
application form and the YES box must be marked.

A sample modified mailing label is available at:  
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  Please note this 
is in PDF format.  

Submit a signed, typewritten original of the application, including the 
Checklist, and three signed photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)

At the time of submission, 2 additional copies of the application must be 
sent to:

David M. Stoff, Ph.D.
Center for Mental Health Research on AIDS
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6210, MSC 9619
Bethesda, MD 20892-9619

Applications must be received by March 20, 2001.  If an application is 
received after that date, it will be returned to the applicant without 
review.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIMH staff.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further consideration.

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by NIMH in accordance with the review criteria stated below.  As 
part of the initial merit review, a process will be used by the initial 
review group in which applications receive a written critique and undergo a 
process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under review, 
will be discussed, assigned a priority score, and receive a second level 
review by the NIMH, NIDA, or NICHD National Advisory Council.

Review Criteria 

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments reviewers will be asked to discuss the following aspects 
of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals.  Each 
of these criteria will be addressed and considered in assigning the overall 
score, weighting them as appropriate for each application.  Note that the 
application does not need to be strong in all categories to be judged likely 
to have major scientific impact and thus deserve a high priority score.  For 
example, an investigator may propose to carry out important work that by its 
nature is not innovative but is essential to move a field forward.

(1) Significance:  Does this study address an important problem?  If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

(3) Innovation:  Does the project employ novel concepts, approaches or 
methods?  Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?

(4) Investigator:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?

(5) Environment:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated.

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research

o  The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the project  
proposed in the application.

Schedule

Letter of Intent Receipt Date:    February 13, 2001
Application Receipt Date:         March 20, 2001
Peer Review Date:                 April 2001
Council Review:                   May/June 2001
Earliest Anticipated Start Date:  September 30, 2001

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  scientific merit (as determined by peer review);
o  availability of funds;
o  programmatic priorities.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:
 
David M. Stoff, Ph.D.
Center for Mental Health Research on AIDS
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6210, MSC 9619
Bethesda, MD 20892-9619
Telephone:  (301) 443-4625
FAX:  (301)443-9719
Email:  dstoff@nih.gov

Ro Nemeth-Coslett, Ph.D.
Clinical Neurobiology Branch
Division of Treatment Research and Development
National Institute on Drug Abuse
6001 Executive Blvd, Room 4238, MSC 9669
Bethesda, MD 20892-9669
Telephone: (301) 443-2805
FAX:  (301) 443-6885
Email:  rn29e@nih.gov

Anne Willoughby, M.D., M.P.H.
Chief, Pediatric, Adolescent and Maternal AIDS Branch
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Blvd – Room 4B113, MSC7510
Bethesda, MD  20892-7510
Telephone:  (301) 402-0699
FAX:   (301) 496-8678
Email:   aw55g@nih.gov

Direct inquiries regarding fiscal matters to:
 
Diana S. Trunnell
Grants Management Branch
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX:  (301) 443-6885
Email:  Diana_Trunnell@nih.gov

Daisey Parker
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Blvd, Room 3126, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6849
Email:  dp64@nih.gov

Christopher Myers
Grants Management Branch 
National Institute of Child Health and Human Development 
6100 Executive Boulevard, Room 8A17F, MSC 7510 
Bethesda Maryland 20892-7510 
Telephone:  (301) 435- 6996 
FAX: (301) 402-0915 
Email:  cm143g@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance 
No. 93.242.  Awards are made under authorization of the Public Health Service 
Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 
USC 241 and 285) and administered under NIH grants policies and Federal 
Regulations 42 CFR and 45 CFR Part 74.  This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and promote the non-use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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